DALLAS/FORT WORTH, Texas, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products for the treatment of attention-deficit/hyperactivity disorder (ADHD), today reported financial results for the third quarter ended September 30, 2016 and provided a business update. "Adzenys XR-ODT™ has been performing very well since our launch in May 2016, as demonstrated by the prescription growth reported by IMS. We are seeing product adoption across both pediatric and adult patient populations and the feedback from physicians and patients continues to be positive," said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. "We also remain on track to resubmit the NDA for Cotempla XR-ODT™, our extended-release methylphenidate ODT product, and to submit the NDA for NT-0201, our extended-release amphetamine liquid suspension, in the fourth quarter of 2016. If approved, we anticipate the launch of both these products during the second half of 2017." Adzenys XR-ODT™ Launch Update
- For the three months ended September 30, 2016, total prescriptions filled for Adzenys XR-ODT, as reported by IMS, were 8,959. For the four-week period ending October 28, 2016, IMS reported an additional 5,177 prescriptions filled for Adzenys XR-ODT.
- Since the launch in May 2016 through October 28, 2016, the cumulative total number of prescriptions filled, as reported by IMS, were 15,186.
- Weekly prescriptions increased approximately 13% per week during the three months ended September 30, 2016.
- Patients switching from another ADHD medication accounted for approximately 75% of all new Adzenys XR-ODT prescriptions, as reported by IMS.
- As of the week ended October 21, 2016, as reported by IMS, 62% of all new Adzenys XR-ODT prescriptions were for pediatric patients and 38% were for adult patients, indicating a broad appeal of Adzenys XR-ODT in all patient types.
- The number of new prescribers has continued to grow since launch. The cumulative total number of prescribers of Adzenys XR-ODT, as reported by IMS through the week ended October 21, 2016, was 2,887.
- Managed care coverage for Adzenys XR-ODT has increased to 83% of lives covered by commercial payers compared to 70% covered lives in the last quarter.
- Resubmit the New Drug Application (NDA) for Cotempla XR-ODT, the Company's methylphenidate extended-release ODT product, in the fourth quarter of 2016.
- Submit the NDA for NT-0201, the Company's amphetamine XR liquid suspension, in the fourth quarter of 2016.
- Total product revenues were $1.6 million for the three months ended September 30, 2016, compared to $0.2 million for the same period in 2015. Adzenys XR-ODT revenues were approximately $0.7 million, and the remainder of the increase is attributed to an increase in sales of the Company's generic Tussionex.
- Gross loss for the three months ended September 30, 2016 was $0.7 million, compared to $1.0 million for the same period of 2015. This improvement was due to increased revenue offset by the cost of goods for the increased volume of product sales.
- Research and development expenses for the three months ended September 30, 2016 were $2.9 million, compared to $2.7 million for the same period in 2015. This increase was primarily due to completion of the bioequivalence studies for Cotempla XR-ODT and NT-0201.
- Selling and marketing expenses were $17.0 million for the three months ended September 30, 2016, compared to $1.4 million for the same period in 2015. The increase is primarily directly attributable to the commercialization of Adzenys XR-ODT, which launched in May 2016.
- General and administrative expenses for the three months ended September 30, 2016 were $3.1 million, compared to $2.0 million for the same period in 2015. This increase was a result of higher professional fees and salary and compensation expenses associated with becoming a public reporting and commercial company.
- The Company reported a net loss of $25.8 million in the three months ended September 30, 2016, compared to $9.4 million for the same period in 2015.
- At September 30, 2016, the Company's cash, cash equivalents and short-term investments amounted to $60.0 million.
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|Neos Therapeutics, Inc. and SubsidiariesCONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)|
|In thousands, except share and per share data||September 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||43,489||$||90,763|
|Accounts receivable, net of allowances of $1,193 and $1,039, respectively||4,263||3,903|
|Other current assets||1,980||1,058|
|Total current assets||71,962||98,244|
|Property and equipment, net||6,952||5,124|
|Intangible assets, net||15,969||16,672|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current portion of long-term debt||3,188||7,973|
|Total current liabilities||21,414||15,938|
|Long-term debt, net of current portion||58,524||26,271|
|Deferred gain on leaseback||60||547|
|Total long-term liabilities||60,123||28,198|
|Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at September 30, 2016 and December 31, 2015||-||-|
|Common stock, $0.001 par value, 100,000,000 authorized at September 30, 2016 and December 31, 2015; 16,079,902 and 16,070,705 issued and outstanding at September 30, 2016 respectively; 16,025,155 and 16,015,958 issued and outstanding at December 31, 2015, respectively||16||16|
|Treasury stock, at cost, 9,197 shares at September 30, 2016 and December 31, 2015||(171||)||(171||)|
|Additional paid-in capital||197,789||195,314|
|Accumulated other comprehensive income||9||-|
|Total stockholders' equity||15,898||78,374|
|Total liabilities and stockholders' equity||$||97,435||$||122,510|
|Neos Therapeutics, Inc. and Subsidiaries CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|For the Three Months Ended September 30,||Nine Months Ended September 30,|
|In thousands, except share and per share amounts||2016||2015||2016||2015|
|Net product sales||$||1583||$||221||$||5,651||$||2,133|
|Cost of goods sold||2,289||1,172||7,301||4,070|
|Research and development||2,910||2,658||8,722||8,965|
|Selling and marketing expenses||16,977||1,399||39,630||2,370|
|General and administrative expenses||3,140||1,967||9,600||4,891|
|Loss from operations||(23,733||)||(6,975||)||(59,602||)||(18,163||)|
|Loss on debt extinguishment||-||-||(1,187||)||-|
|Other income, net||155||518||716||623|
|Change in fair value of earnout and warrant liabilities||(98||)||(1,867||)||(141||)||(1,452||)|
|Preferred stock accretion to redemption value||-||(99||)||-||(1,169||)|
|Preferred Stock Dividends||-||(138||)||-||(1,221||)|
|Net loss attributable to common stock||$||(25,806||)||$||(9,605||)||$||(64,960||)||$||(24,067||)|
|Weighted average common shares outstanding used to compute net loss per share, basic and diluted||16,070,705||12,403,182||16,048,801||4,767,479|
|Net loss per share of common stock, basic and diluted||$||(1.61||)||$||(0.77||)||$||(4.05||)||$||(5.05||)|
Contacts: Richard EisenstadtChief Financial OfficerNeos Therapeutics(972) email@example.comSarah McCabeStern Investor Relations, Inc.(212) firstname.lastname@example.org